Section 100.310 - Standard Conditions(A)Applicability. Unless otherwise expressly specified within 105 CMR 100.000, each Notice of Determination of Need issued by the Department shall be subject to the following Conditions. The Commissioner may specify additional Standard Conditions through Guideline which shall be attached to all Notices of Determination of Need, unless otherwise specified, and which shall be determined by the Commissioner as advancing the objectives of 105 CMR 100.000. Prior to issuance, such Guideline shall be developed through a public process that includes consultation with applicable Government Agencies, community-based organizations, relevant stakeholders, and the Public Health Council.(1) The Notice of Determination of Need shall be subject to administrative review by the Health Facilities Appeals Board and may be stayed by the Health Facilities Appeals Board. If the Health Facilities Appeals Board is not constituted on the date of issuance of the Notice of Determination of Need, the Notice shall be considered a Final Action subject to review under M.G.L. c. 30A.(2) The Notice of Determination of Need shall go into effect upon the Department's issuance of a written notification made pursuant to 105 CMR 100.625(A). The Holder shall submit an acknowledgment of receipt to the Department within 30 days of the written notification, signed by the Holder's chief executive officer and board chair, and returned to the Department and all Parties of Record. Unless extended for Good Cause Related to Project Implementation, or as a result of an approved amendment to a previously issued Notice of Determination of Need, the Notice of Determination of Need shall constitute a valid authorization for a period of not more than three years following the approval of the Department, unless otherwise expressly noted as an Other Condition, and shall only be for the purposes of the approved project, including for the identified and approved treatments and/or patient populations. No Notice of Determination of Need shall remain in authorization unless the Holder complies with all prescribed terms and Conditions set forth by the Department. Any Notice of Determination of Need issued to a Holder that is subject to a Cost and Market Impact Review pursuant to M.G.L. c. 6D, § 13 and 958 CMR 7.00: Notices of Material Change and Cost and Market Impact Reviews shall not go into effect until 30 days following HPC's completed Cost and Market Impact Review.(3) Unless extended for Good Cause Related to Project Implementation, or as a result of an approved amendment to a previously issued Notice of Determination of Need, the Notice of Determination of Need shall constitute a valid authorization only for the Proposed Project for which the Notice of Determination of Need is made, and for only the total Capital Expenditure approved.(4) The Notice of Determination of Need shall constitute a valid authorization only for the Person to whom it is issued and may be transferred only upon the expressed written permission of the Department pursuant to 105 CMR 100.635(A), except that: (a) the Holder of a Notice of Determination of Need for a Transfer of Ownership issued pursuant to 105 CMR 100.735 becomes the Holder of any Notice of Determination of Need then held by any entity being transferred;(b) for any Transfer of Ownership not subject to 105 CMR 100.735, where the Health Care Facility being acquired is the Holder of a Notice of Determination of Need which is still in effect pursuant to 105 CMR 100.310(17), the transferee must provide Notice to the Department in a form and manner determined by the Commissioner that it will assume all obligations and comply with all Conditions and requirements of such Notice of Determination of Need; and(c) for any Transfer of Ownership not subject to 105 CMR 100.735 where the Health Care Facility being acquired is the Holder of an unimplemented Notice of Determination of Need issued before January 27, 2017, at the time that a license is issued to the transferee, pursuant to 105 CMR 153.000: Licensure Procedure and Suitability Requirements for Long-term Care Facilities, the transferee becomes the Holder of any Notice of Determination of Need then held by any entity being acquired. Following the transfer, the Holder may implement the Notice of Determination of Need as approved, unless implementation requires any Significant Change, in which case the Holder must comply with the requirements of 105 CMR 100.635. Notwithstanding the exceptions above, a Notice of Determination of Need issued for an Original License pursuant to 105 CMR 100.730 and a Notice of Determination of Need for a Transfer of Ownership pursuant to 105 CMR 100.735 shall not be transferable.
(5) The authorization for the Notice of Determination of Need shall expire if the Department determines that Substantial and Continuing Progress is not made, or if not duly extended by the Department for Good Cause Related to Project Implementation shown. Any request for an extension must be filed by the Holder within the period of authorization for the Notice of Determination of Need. In the event an appeal is filed with the Health Facilities Appeals Board, the period of authorization of the Notice of Determination of Need shall be extended during such time that any stay is in effect.(6)(a) Notwithstanding the period of authorization of the Notice of Determination of Need, if the Holder is subject to the requirements of filing final architectural plans and specifications pursuant to M.G.L. c. Ill, § 51 or § 71, and if any Construction or renovation is involved, the Notice of Determination of Need shall not remain in force longer than 12 months unless, within said 12 months, the Holder has filed such final architectural plans and specifications; provided that the Commissioner may approve a written schedule for the phased submission of such plans beyond that period for any project involving Construction having an authorized Capital Expenditure in excess of an amount equal to the Expenditure Minimum with respect to Substantial Capital Expenditures with respect to Hospitals. In the event a written schedule for phased submission of such plans is approved, each portion of the project to which a submission relates shall be consistent with the overall project as approved by the Department and shall not exceed the proportional share of the total approved project cost.(b) Failure to submit final and complete architectural plans and specifications plans by the date specified by the Department, or by an approved schedule for plan submission pursuant to 105 CMR 100.310(A)(6), may result in:1. the initiation of revocation procedures pursuant to 105 CMR 100.640; or2. the disallowance of inflation calculated pursuant to 105 CMR 100.310(A)(9) for the amount of time equal to the time period between the due date for submission of final plans as prescribed by the Department, and the date of actual submission by the Holder. The disallowance of inflation for this time period shall be calculated as if the time period occurred immediately preceding the commencement of Construction.(c) No Construction may begin pursuant to a Notice of Determination of Need until the Holder has met all applicable Department and other Government Agency licensure requirements, including plan review. Part 1 Plan Review by the Department may coincide, as is reasonably feasible, with Department consideration of a Proposed Project pursuant to 105 CMR 100.000.(d) The Holder shall ensure Construction of any new building or the complete rehabilitation of a building implemented pursuant to a Notice of Determination of Need shall meet all Prerequisites and meet or exceed certifiable "silver level", or equivalent, of the Leadership in Energy and Environmental Design-Health Care (LEED-HC) Green Guide for Healthcare (GGHC), or an equivalent nationally recognized best practice standard, as approved by the Department(7) The written schedule for the phased submission of architectural plans and specifications submitted by the Holder pursuant to 105 CMR 100.310(6) shall be used to measure continuing progress toward completion of the project for which a Notice of Determination of Need has been issued.(8) The Government Agency license of the Health Care Facility or Health Care Facilities, for which and on behalf of, the Holder possesses a valid Notice of Determination of Need, shall be conditioned with all Standard and Other Conditions attached to the Notice of Determination of Need.(9) Unless extended for Good Cause Related to Project Implementation, the Department shall receive from the Holder firm, itemized figures specifying the final project costs, or current phase thereof, which shall not be greater than those approved by the Department pursuant to the issued Notice for Determination of Need plus any increase in cost due to the allowable rate of inflation. This submission shall occur within six months following the receipt of written final approval of architectural plans and specifications by the Department or other applicable Government Agency; or, in the case of projects for which a schedule of phased plan submission has been approved, each phase submitted. The Holder shall submit the final project costs in a format specified by the Commissioner. No additional increases in the maximum Capital Expenditure, inflationary or otherwise, shall be approved beyond 12 months after the initial licensure of beds and opening of the facility or service. The final approved project costs shall be submitted by the Commissioner to all Parties of Record. Should the Holder fail to submit final project costs pursuant to 105 CMR 100.310(A)(9), the Holder shall be subject to enforcement actions as set forth within the Notice of Determination of Need's Standard and Other Conditions.(10) Unless explicitly exempt within 105 CMR 100.000, the terms and Conditions shall require that the Holder develop a Plan which shall document the Holder's obligations pursuant to 105 CMR 100.210(A)(6). Said plan shall require the Holder to expend, over a five-year period, or any other period as specified by the Commissioner, an amount which in total shall be greater than or equal to 5% of the total Capital Expenditure of the approved project, except in cases where exemptions within 105 CMR 100.000 may apply. Said projects shall address one or more of the Health Priorities set out in Department Guidelines.(11) If the Health Care Facility or Heath Care Facilities for which the Notice of Determination of Need has been issued is eligible, the Holder shall provide written attestation on behalf of the Health Care Facility or Heath Care Facilities, under the pains and penalties of perjury, of participation, or their intent to participate, in MassHealth pursuant to 130 CMR 400.000 through 499.000.(12) The Holder shall report to the Department, at a minimum on an annual basis, and in a form, manner, and frequency as specified by the Commissioner. At a minimum, said reporting shall include, but not be limited to, the reporting of measures related to the project's achievement of the Determination of Need Factors, as directed by the Department pursuant to 105 CMR 100.210.(13) If it is determined by the Department that the Holder has failed to sufficiently demonstrate compliance with one or more Conditions, the Holder shall fund projects which address one or more of the Health Priorities set out in Department Guideline, as approved by the Department, which in total, shall equal up to 2.5% of the total Capital Expenditure of the approved project. Said projects shall address one or more of the Health Priorities set out in Department Guideline, and shall be in addition to those projects approved by the Department in fulfillment of 105 CMR 100.210(A)(6). In making such determination, the Department shall provide written notification to the Holder at least 30 days prior to requiring such funding, and shall provide the Holder the opportunity to appear before the Department. The Department shall consider circumstances external to the Holder that may impact the Holder's ability to demonstrate compliance.(14) The Holder shall provide to Department Staff a plan for approval by the Office of Health Equity for the development and improvement of language access and assistive services provided to the Holder's Patient Panel, including individuals with disabilities and patients who do not speak English, or have Limited English Proficiency (LEP), or use American Sign Language (ASL).(15) The Holder shall provide for interpreter services to the Holder's Patient Panel. The Holder shall ensure that all medical and non-medical interpreters, inclusive of staff, contractors, and volunteers providing interpreter services to the Holder's Patient Panel maintain current multilingual proficiency and have sufficient relevant training. Training for non-medical interpreters should include, at a minimum:(a) the skills and ethics of interpretation; and(b) cultural health beliefs systems and concepts relevant to non-clinical encounters.(c) Training for medical interpreters should include, at a minimum: 1. the skills and ethics of interpretation; and2. multilingual knowledge of specialized terms, including medical terminology, competency in specialized settings, continuing education, and concepts relevant to clinical and non-clinical encounters.(16) The Holder shall require and arrange for ongoing education and training for administrative, clinical, and support staff in culturally and linguistically appropriate services (CLAS) including, but not limited to, patient cultural and health belief systems and effective utilization of available interpreter services.(17) All Standard and Other Conditions attached to the Notice of Determination of Need shall remain in effect for a period of five years following completion of the project for which the Notice of Determination of Need was issued, unless otherwise expressly specified within one or more Condition.(18) In the event that the Holder is required by the Health Policy Commission to develop and file a Performance Improvement Plan (PIP) pursuant to 958 CMR 10.00: Performance Improvement Plans, then the Holder shall report to the Department that the Holder has filed the PIP and is engaged in ongoing efforts to implement the PIP consistent with 958 CMR 10.00. The Holder will timely provide all information necessary for CHIA to perform its analysis required by M.G.L. c. 12C, § 18 and for the HPC to determine if the Holder must develop and file a PIP. If the HPC finds the Holder has not fully complied with the requirements of the PIP implementation process, as set forth in 958 CMR 10.00, then, notwithstanding the HPC finding, the Holder shall report to the Department on why the Department should find that the Holder is still in compliance with the terms and conditions of the Notice of Determination of Need.(B)(1) A Determination of Need Application for Transfer of Ownership pursuant to 105 CMR 100.735 is exempt from 105 CMR 100.310(A)(5), (6), (7), (9), (10) and (13).(2) A Determination of Need issued for a Conservation Project or for a Long-term Care Facility is exempt from 105 CMR 100.310(A)(10).(3) Unless otherwise specified by the Department, a Notice of Determination of Need issued to a Holder resulting from an Emergency Application pursuant to 105 CMR 100.740 shall be subject to all Standard Conditions specified in 105 CMR 100.310, except 105 CMR 100.310(A)(10).Adopted by Mass Register Issue S1331, eff. 1/27/2017.Amended by Mass Register Issue 1381, eff. 12/28/2018.